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Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

Diabetic Foot Ulcer Clinical Trial

Official title:
A Randomized Controlled Multicenter Trial Examining the Effect of Derm-Maxx ADM on the Healing Rate of Chronic Diabetic Foot Ulcers

Clinical Trial Summary

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers

Clinical Trial Description

This is a multicenter randomized open-label clinical study in patients with Wagner grade 1 and 2 DFUs. Diabetic patients presenting with chronic nonhealing ulcers will be screened for eligibility. At least 50% of the eligible population will be drawn from patients ≥ 65 years of age. All patients will complete a 2-week run-in period prior to treatment allocation to Derm-Maxx and standard of care (SOC) or SOC alone. Patients will be seen at weekly intervals (± 3 days) for the 12 weeks treatment period. If additional dressing changes are required between the scheduled visits, the occurrence of these visits will be recorded. Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure. Additionally, pain and safety will be assessed as secondary endpoints. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06455475
Study type Interventional
Source Capsicure, LLC
Contact Sarah Moore, BSN, MBE
Phone 512-571-2966
Email smoore@capsicure.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date September 2025
View Details
See also
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